Trastuzumab Biosimilars Landscape Report 2020 Featuring 36 Key Players & 32 Key Products – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Trastuzumab – Biosimilars Insight, 2020” report has been added to ResearchAndMarkets.com’s offering.

This Trastuzumab- Biosimilar Insight, 2020 report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Trastuzumab Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Trastuzumab: Overview

Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. It is specifically used for cancer that is HER2 receptor positive. It may be used by itself or together with other chemotherapy medication. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2.

Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic gentamicin. Gentamicin is not detectable in the final product. Herceptin (trastuzumab) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration.

Trastuzumab Biosimilars: Drugs Chapters

This segment of the Trastuzumab report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. (Read more…) It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Trastuzumab Biosimilars: Marketed Drugs

Kanjinti: Amgen

Kanjinti is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of KANJINTI is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as trastuzumab. Kanjinti has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.

Herzuma: Celltrion

Herzuma is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer. Herzuma is the second FDA-approved trastuzumab biosimilar, following Mylan and Biocon’s approval for Ogivri in December 2017 (Ogivri has not yet launched in the United States). Herzuma has also earned approval in the European Union (where it is marketed by Mundipharma), in Japan (where it is marketed by Daiichi Sankyo), and in Australia.

Trastuzumab Biosimilars: Emerging Drugs

EG12014: EirGenix

EG12014 is a biosimilar of trastuzumab, which is Roche’s monoclonal antibody with brand name called Herceptin. A biosimilar drug is a near-identical copy of an original biologics and a different company can manufacture it after the expiration of the original biologics’ patent. Eirgenix has begun preparations for a phase III clinical trial which would be conducted in the US and European nations. The outcome paves the way for new opportunities for lower-priced biosimilar drugs as patents on mainstream oncology drugs approach their expiration dates in the next few years.

HD201: Prestige BioPharma

HD201 is a mAb biosimilar to Roche’s Herceptin which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Prestige’s HD201 is in phase-III clinical development for filing with European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2019.

Trastuzumab: Therapeutic Assessment

This segment of the report provides insights about the different Trastuzumab biosimilars segregated based on following parameters that define the scope of the report, such as:

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Trastuzumab R&D. The therapies under development are focused on novel approaches to treat/improve Trastuzumab.

In June 2019, Amgen and Allergan announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Trastuzumab Biosimilars?
• How many Trastuzumab biosimilars are developed by each company?
• How many emerging biosimilars are in mid-stage, and late-stage?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Trastuzumab biosimilars therapeutics?
• What are the clinical studies going on for Trastuzumab biosimilars and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Sunshine Guojian Pharmaceutical
• STC Biologics
• Shanghai Institute of Biological Products
• Samsung Bioepis
• Protheragen
• Prestige Biopharma
• Outlook Therapeutics
• Nichi-Iko Pharmaceutical
• Aprogen
• NeuClone
• Serum Institute of India
• Mycenax Biotech
• Meiji Seika Pharma
• Mabpharm
• Mabion
• Jiangsu Hengrui Medicine Co.
• ISU Abxis
• International Biotech Center Generium
• HisunPharmaceuticals
• Hetero Group
• Glenmark Pharmaceuticals
• Genentech
• Gedeon Richter
• EirGenix
• Dr Reddy’s Laboratories
• DM Bio
• BioXpress Therapeutics
• BioSavita
• Bionovis
• BioIntegrator
• BIOCND
• Biocad
• AryoGen Pharmed
• Apobiologix
• Alteogen
• Shanghai Henlius Biotech

Key Products

• Cipterbin
• STC 101
• SIBP 01
• SB3
• Pro-S06
• HD 201
• ONS-1050
• NeuCeptin
• DMB-3111
• CMAB 809
• MabionHER2
• SHR-1309
• ISU103
• GNR-027
• HS-022
• HBP7
• HBP8
• HBP9
• HBP10
• GBR-200
• Anti-erbB-2- monoclonal antibody
• EG12014
• Hervycta
• DA-3111
• BX-2318
• Anti-HER2 mAb biosimilar
• BI-MAB-03
• GB 221
• BCD-022
• AryoTrust
• ALT02
• HLX02

For more information about this report visit https://www.researchandmarkets.com/r/loy1if

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